Εθνικό Σύστημα Διαπίστευσης ΑΕ



Hellenic Accreditation System

[pic]

|Annex to the G1/8 Certificate No. 907-2 |

| |

|SCOPE of ACCREDITATION |

|of the |

|Diagnostic Laboratory |

|of |

|LABOGEN Immunology Private Diagnostic Laboratory Medical S.A. (LABOGEN S.A.) |

|Materials/Products tested |Types of test/Properties measured |Applied methods/Techniques used |

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|Blood serum |Determination of 25 parameters |Automated immunochemical analyzer ABBOTT Architect |

| | |ci 16200, ci8200* |

| | |Quality Manual Annex 1 version 5/8.10.2019 |

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|Blood serum (continued) | | |

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| |1.Glucose |Colorimetric assay with Hexokinase /G-6-PDH |

| |2.Urea |Urease Method |

| |3.Creatinine |JAFFE Method Kinetic Alkaline Picrate |

| |4.Uric acid |Hexokinase Method |

| |5.Triglycerides |Enzymatic reaction with Glycerol Phosphate Oxidase |

| |6.Cholesterol (total) |Enzymatic reaction |

| |7.Cholesterol (HDL) |Enzymatic reaction with Accelerator Selective |

| | |Detergent |

| |8.Aspartateaminotransferase (AST/GOT) |NADH (without P-5’-P) |

| |9.Alanine aminotransferase (ALT/GPT) |NADH (without P-5’-P) |

| |10.Gamma-glutamyl trasferase (γ-GT) |Enzymatic reaction with |

| | |L-gamma-glutamyl-3-carboxy-4-nitroanilide Substrate |

| |11.Alkaline Phosphatase(ALP) |Colorimetric assay with Para-nitrophenyl Phosphate |

| |12.Creatine kinase (CPK) |Colorimetric assay with N-acetyl-L-cysteine (NAC) |

| |13.Lactate dehydrogenase (LDH) |IFCC, lactate to pyruvate |

| |14.Amylase |Enzymatic kinetic with CNPG3 Substrate |

| |15.Total Protein (TP) |Biuret Method |

| |16.Albumin (ALB) |Colorimetric assay with Bromocresol purple |

| |17.Total Bilirubin (TBIL) |Diazonium salt |

| |18.Direct Bilirubin (DBIL) |Diazo reaction |

| |19.Iron (Fe) |Colorimetric assay with Ferene |

| |20.Potassium (K) |Indirect, with ion-selective electrode diluted |

| | |potentiometry |

| |21.Sodium (Na) |Indirect, with ion-selective electrode diluted |

| | |potentiometry |

| |22.Clorine (Cl) |Indirect, with ion-selective electrode diluted |

| | |potentiometry |

| |23.Calcium (Ca) |Colorimetric assay with Arsenazo III |

| |24.Phosphorus (P) |Photometric with Phosphomolybdenic Acid |

| |25.Magnesium (Mg) |Enzymatic (isocitrate deydrogenase) |

| |Determination of 8 parameters |Automated immunochemical analyzer ABBOTT Architect |

| | |ci16200* |

| | |Quality Manual Annex 1 version 5/8.10.2019 |

| |1.Immunoglobulin Α (IgG) |Immunoturbidimetric |

| |2.Immunoglobulin G (IgA) | |

| |3.Immunoglobulin Μ (IgM) | |

| |plement C3 | |

| |plement C4 | |

| |6.C reactive protein CRP |Immunoturbidimetric with latex |

| | |microparticles |

| |7.Rheumatoid Factor RF | |

| |8.Antistreptolycin-O (ASO) | |

|Immunological Tests |

| |Determination of 3 parameter |Automated immunochemical analyzer ABBOTT Architect |

|Blood serum | |ci 16200, ci8200 * |

| | |Quality Manual Annex 1 version 5/8.10.2019 |

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|Blood serum (continued) | | |

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|Blood serum (continued) | | |

| |1.Ferritin (Ferr) |Chemiluminescent Microparticle Immunoassay CMIA |

| |2.Vitamin B-12 | |

| |3.Folate acid | |

| |Determination of 1 parameter |Automated immunochemical analyzer ABBOTT Architect |

| | |ci8200* |

| | |Quality Manual Annex 1 version 5/8.10.2019 |

| |Insulin |Chemiluminescent Microparticle Immunoassay CMIA |

| |Determination of 1 parameter |Automated immunochemical analyzer ABBOTT Architect |

| | |ci16200* |

| | |Quality Manual Annex 1 version 5/8.10.2019 |

| |Valproic Acid |Chemiluminescent Microparticle Immunoassay CMIA |

| |Determination of 3 parameters |Automated immunochemical analyzer ABBOTT Architect |

| | |i2000* |

| | |Quality Manual Annex 1 version 5/8.10.2019 |

| |1.Thyroid - stimulating hormone (TSH) |Chemiluminescent Microparticle Immunoassay CMIA |

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| |2.Parathormone (PTH) | |

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| |3. 25 (ΟΗ) Vitamin D | |

| |Determination of 12 parameters |Automated immunochemical analyzer ADVIA CENTAUR XP* |

| | |Quality Manual Annex 1 version 5/8.10.2019 |

| |1.Triidothyronine total (T3) |Chemiluminescent CLIA |

| |2.Free Triidothyronine (FT3) | |

| |3.Thyroxin total (T4) | |

| |4.Free Thyroxin (FT4) | |

| |5.Thyroid - stimulating hormone (TSH) | |

| |6.Alpha-fetoprotein (AFP) | |

| |7.Carcinoembryonic antigen (CEA) | |

| |8.Prostate-specific antigen (PSA) | |

| |9.Cancer marker CA 15.3 | |

| |10.Cancer marker CA 125 | |

| |11.Cancer marker CA 19.9 | |

| |12.Immunoglobulin E (IgE) | |

| |Determination of 16 parameters |Automated immunochemical analyzer COBAS e601 Roche* |

| | |Παράρτημα 1 εγχειριδίου ποιότητας έκδοση 5/8.10.2019|

| |1.Follicle stimulating hormone (FSH) |Electrochemiluminescence Immunoassay ECLIA |

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| |2.Luteinizing Hormone | |

| |(LH) | |

| |3.Prolactin (PRL) | |

| |4.Estradiol (E2) | |

| |5.Progesterone (PRG) | |

| |6.B-Human chorionic gonadotropin (β-HCG) | |

| |7.Total Testosterone (TESTO-T) | |

| |8.Dehydroepiandrosterone-sulfate (DHEA-S) | |

| |9.Sex hormone-binding globulin (SHBG) | |

| |10.Cortisol (CORT) | |

| |11.Thyroglobubin (Tg) | |

| |12.Hepatitis B surface antigen (HBsAg) | |

| |13.Hepatitis B surface antibody(HBsAb | |

| |14.Hepatitis C antibodies (anti HCV) | |

| |15.HIV1/2 antibodies & HIV1 p24 antigen (Anti HIV) | |

| |16.Hepatitis A total antibodies(anti HAV) | |

| |Determination of 8 parameters |Automated immunochemical analyzer ABBOTT Alinity* |

| | |Quality Manual Annex 1 version 5/8.10.2019 |

| |1.Toxoplasma IgG antibodies |Chemiluminescent Microparticle Immunoassay CMIA |

| |2.Toxoplasma IgM antibidies | |

| |3.Rubella virus IgG antibodies | |

| |4.Rubella virus IgM antibodies | |

| |5.Cytomegalovirus IgG antibodies (CMV IgG) | |

| |6.Cytomegalovirus IgM antibodies (CMV IgM) | |

| |7.ΕΒV IgG-Epstein Barr Virus Antibody IgG | |

| |8. ΕΒV IgM- Epstein Barr Virus Antibody IgM | |

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|Immunochemical Tests |

|Blood serum |Determination of 201 allergens (Specific immunoglobulin IgE - |Automated immunochemical analyzer Immulite 2000 XPi*|

| |RAST) |Quality Manual Annex 1 version 5/8.10.2019 |

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|Blood serum (continued) | | |

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|Blood serum (continued) | | |

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|Blood serum (continued) | | |

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|Blood serum (continued) | | |

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|Blood serum (continued) | | |

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|Blood serum (continued) | | |

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|Blood serum (continued) | | |

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| |c1 Penicilloyl G | |

| | |Chemiluminescent CLIA |

| |c2 Penicilloyl V | |

| |c203 Ampicillin | |

| |c204 Amoxicillin | |

| |d1 Dermatophagoides pteronyssinus | |

| |d2 Dermatophagoides farinae | |

| |d3 Dermatophagoides microceras | |

| |d70 Acarus siro | |

| |d71 Lepidoglyphus destructor | |

| |d72 Tyrophagus putrescentiae | |

| |d73 Glycyphagus domesticus | |

| |e1 Cat Dander-Epithelium | |

| |e2 Dog epithelium | |

| |e3 Horse dander | |

| |e4 Cow dander | |

| |e5 Dog dander | |

| |e70 Goose feathers | |

| |e71 Mouse epithelium | |

| |e80 Goat epithelium | |

| |e81 Sheep epithelium | |

| |e82 Rabbit epithelium | |

| |e85 Chicken feathers | |

| |e86 Duck feathers | |

| |e215 Pigeon feathers | |

| |f1 Egg white | |

| |f2 Milk | |

| |f3 Codfish | |

| |f4 Wheat | |

| |f5 Rye | |

| |f6 Barley | |

| |f7 Oat | |

| |f8 Corn | |

| |f9 Rice | |

| |f10 Sesame seed | |

| |f11 Buckwheat | |

| |f12 Green pea | |

| |f13 Peanut | |

| |f14 Soybean | |

| |f15 White bean | |

| |f17 Hazelnut | |

| |f18 Brazil nut | |

| |f20 Almond | |

| |f23 Crab | |

| |f24 Shrimp | |

| |f25 Tomato | |

| |f26 Pork | |

| |f27 Beef | |

| |f31 Carrot | |

| |f33 Orange | |

| |f35 Potato | |

| |f36 Coconut | |

| |f37 Blue Mussel | |

| |f40 Tuna | |

| |f41 Salmon | |

| |f44 Strawberry | |

| |f45 Baker's yeast | |

| |f47 Garlic | |

| |f48 Onion | |

| |f49 Apple | |

| |f59 Octopus | |

| |f61 Sardine | |

| |f75 Egg yolk | |

| |f76 Alpha Lactalbumin | |

| |f77 Beta Lactoglobulin | |

| |f78 Casein | |

| |f79 Gluten | |

| |f80 Lobster | |

| |f81 Cheese,Cheddar | |

| |f82 Cheese,Mold-type | |

| |f83 Chicken meat | |

| |f84 Kiwi Fruit | |

| |f85 Celery | |

| |f86 Parsley | |

| |f87 Melon | |

| |f88 Lamb | |

| |f89 Mustard | |

| |f90 Malt | |

| |f92 Banana | |

| |f93 Cacao | |

| |f94 Pear | |

| |f95 Peach | |

| |f96 Avocado | |

| |f105 Σοκολάτα | |

| |f170 Swiss cheese | |

| |f202 Cashew | |

| |f203 Pistachio | |

| |f204 Trout | |

| |f208 Lemon | |

| |f210 Pineapple | |

| |f212 Mushroom | |

| |f213 Rabbit | |

| |f214 Spinach | |

| |f215 Lettuce | |

| |f216 White cabbage | |

| |f221 Coffee | |

| |f222 Tea | |

| |f231 Boiled milk | |

| |f232 Ovalbumin | |

| |f233 Ovomucoid | |

| |f235 Lentil | |

| |f237 Apricot | |

| |f242 Cherry | |

| |f245 Egg | |

| |f247 Honey | |

| |f255 Plum | |

| |f256 Walnut | |

| |f258 Squid | |

| |f259 Grape | |

| |f260 Broccoli | |

| |f262 Eggplant | |

| |f280 Black Pepper | |

| |f284 Turkey Meat | |

| |f291 Cauliflower | |

| |f299 Chestnut | |

| |f302 Mandarin | |

| |f309 Chick pea | |

| |f402 Fig | |

| |f409 Goat's Milk | |

| |g1 Sweet Vernal Grass | |

| |g2 Bermuda grass | |

| |g3 Orchard grass | |

| |g4 Meadow Fescue | |

| |g5 Perennial Rye grass | |

| |g6 Timothy grass | |

| |g7 Common Reed Grass | |

| |g8 June Grass | |

| |g9 Red Top | |

| |g10 Johnson Grass | |

| |g11 Brome Grass | |

| |g12 Cultivated Rye Grass | |

| |g13 Velvet grass | |

| |g14 Cultivated Oat Grass | |

| |g15 Cultivated Wheat Grass | |

| |g16 Meadow Foxtail Grass | |

| |g17 Bahia grass | |

| |g70 Wild Rye Grass | |

| |g71 Canary Grass | |

| |g202 Cultivated Corn | |

| |h1 House dust -Greer | |

| |i1 Honey Bee venom | |

| |i2 White-faced Hornet | |

| |i3 Yellow Jacket Venom | |

| |i4 Paper wasp Venom | |

| |i5 Yellow hornet | |

| |i6 Cockroach | |

| |i70 Imported Fire Ant | |

| |i71 Mosquito | |

| |i75 European Hornet | |

| |k20 Wool | |

| |k74 Silk | |

| |k82 Latex | |

| |m1 Penicillium notatum | |

| |m2 Cladosporium herbarum | |

| |m3 Aspergilus fumigatus | |

| |m4 Mucor racemosus | |

| |m5 Candida albicans | |

| |m6 Alternaria tenuis | |

| |m7 Botrytis cinerea | |

| |m8 Helminthosporium halodes | |

| |m9 Fusarium moniliforme | |

| |m207 Aspergillus niger | |

| |p1 Ascaris | |

| |p4 Anisakis | |

| |t1 Maple | |

| |t2 Alder | |

| |t3 Birch | |

| |t4 Hazelnut | |

| |t5 Beech | |

| |t6 Mountain Cedar | |

| |t7 Oak | |

| |t8 Elm | |

| |t9 Olive | |

| |t10 Walnut | |

| |t11 Sycamore | |

| |t12 Willow | |

| |t14 Cottonwood | |

| |t15 White Ash | |

| |t16 White Pine | |

| |t18 Eucalyptus | |

| |t19 Acacia | |

| |t23 Italian Cypress | |

| |t70 White Mulberry | |

| |t201 Spruce | |

| |t210 Privet | |

| |w1 Common Ragweed | |

| |w2 Western Ragweed | |

| |w3 Giant Ragweed | |

| |w4 False Ragweed | |

| |w5 Wormwood | |

| |w6 Mugwort | |

| |w7 Ox-Eye Daisy | |

| |w8 Dandelion | |

| |w9 English Plantain | |

| |w10 Lamp's Quarters | |

| |w11 Russian Thistle | |

| |w12 Goldenrod | |

| |w13 Cocklebur | |

| |w14 Rough Pigweed | |

| |w16 Rough Marsh Elder | |

| |w18 Sheep Sorrel | |

| |w19 Parietaria officinalis | |

| |w20 Nettle | |

| |w21 Parietaria Judaica | |

|Blood serum |Determination of 16 allergens panels |Automated immunochemical analyzer Immulite 2000 XPi*|

| | |Quality Manual Annex 1 version 5/8.10.2019 |

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| |EP1 Animal panel 1 - (E1, E3, E4, E5) |Chemiluminescent CLIA |

| |EP71 Animal panel 71 - (E70, E85, E86, E89) | |

| |FP1 Food panel 1 - Nut Mix (f13,17,18 ,20,36) | |

| |FP2 Food panel 2 - Fish/Shell (f3,24,37,40,41) | |

| |FP3 Food panel 3 - Cereals Mix (f4,7,8,10,11) | |

| |FP73 Food panel 73 - Meat Mix (f26,27,83,88) | |

| |FP13 Food panel 13 (f12,15,31,35) | |

| |FP15 Food panel 15 - Fruit Mix (f33,49,92,95) | |

| |GP1 Grass panel 1 (g3,4,5,6,8) | |

| |GP4 Grass panel 4 (g1,5,7,12,13) | |

| |HP1 House panel 1(d1,d2,h1,i6) | |

| |MP1 Mold panel 1 (m1,2,3,5,6) | |

| |TP5 Tree panel 5 (t2,4,8,12,14) | |

| |TP6 Tree panel 6 (t1,3,5,7,10) | |

| |WP1 Weed panel 1 (w1,6,9,10,11) | |

| |WP5 Weed panel 5 (w1,6,7,8,12) | |

| |

|Hematological Tests |

|Whole blood (EDTA) |Determination of 1 parameter |Chromatographic analyzer VARIANT II TURBO Bio-Rad* |

| | |Quality Manual Annex 1 version 5/8.10.2019 |

| |1.Determination of glycated hemoglobin A1c (HbA1C ) |HPLC (ion exchange High-performance chromatography) |

* Reference to the commercial name of a specific analyzer refers to a specific analytical method and protocol

Site of assessment: Permanent premises, 37-39 Antheon str., Athens, Greece.

Approved signatories: F. Vlasopoulou, P. Makridou.

This scope of Accreditation replaces the previous one dated 20.12.2021.

The Accreditation Certificate No. 907-2, to ELOT EN ISO 15189:2012, has been expanded until 13.08.2022.

Athens, Junuary 10, 2022

Christos Nestoras

CEO of ESYD

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Biochemical Testing

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